Follicular lymphoma
Conditions
Interventions
experimental group:low-dose dicitabine combined with triplezumab
Sponsors
Cancer Prevention and Treatment Center, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with refractory or recurrent follicular lymphoma diagnosed by histopathology / clinical imaging. 2. Male or female patients: 18-80 years old. 3. ECoG physical condition score: 0-2 points for patients. 4. Patients with expected survival >= 3 months. 5. In those patients with at least one evaluable or measurable lesion meeting Lugano 2014 criteria, the evaluable lesion was: 18F fluorodeoxyglucose / positron emission tomography (18FDG / PET) examination showed that the uptake of lymph nodes or extranodal areas was increased (higher than that of liver) and pet and / or computed The features of tomography (CT) were in accordance with lymphoma. The measurable lesions were nodal lesions with a length of > 15 mm or extranodal lesions with a length of > 10 mm, accompanied by an increase in 18FDG uptake. There was no measurable lesion and the uptake of 18FDG was increased. 6. Patients who failed in the second-line treatment were at least 4 weeks away from the last treatment and at least 3 months away from the transplantation of autologous stem cells. 7. Patients with good function of main organs, i.e. one week before admission, met the following requirements: WBC >= 3 x 10^9 / L, Hb >= 80g / L, PLT >= 80 x 10^9 / L; heart and liver functions were normal (total bilirubin <= 1.5 times of normal value, ALT and AST <= 2.5 times of normal value), renal functions were normal (serum creatinine <= 1.5 times of normal value), and coagulation function was not abnormal. 8. Pregnant women of childbearing age must have a pregnancy test (serum or urine) within 14 days before enrollment and the result is negative, and they are willing to use reliable methods of contraception during the test. 9. The subjects who volunteer to join the study and sign the informed consent form, have good compliance and cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with definite transformed lymphoma. 2. Patients with organ failure. Heart: Grade III and IV; liver: Grade C of child Turcotte liver function grade; kidney: renal failure and uremia; lung: severe respiratory failure; brain: people with consciousness disorder. 3. Patients with uncontrollable infectious diseases or other serious diseases, such as HIV positive. 4. Patients with systemic autoimmune disease or immunodeficiency. 5. Patients with a history of organ transplantation. 6. Patients with allergic constitution. 7. Patients with chronic diseases requiring immunotherapy or hormone therapy. 8. Patients with active gastrointestinal bleeding or gastrointestinal bleeding in recent 1 month. 9. Patients with active infection, especially lung and intestinal infection. 10. Patients taking glucocorticoids or immunosuppressants in the past week. 11. In the past 4 weeks, patients who received other antibody treatment, including PD-L1 / L2, CTLA-4 and other antibodies, or targeted T cell costimulatory factors. 12. Patients with substance abuse or mental or other disorders that may interfere with study compliance. 13. Patients who have participated in other clinical trials in the past 30 days. 14. Any situation that is unstable or may endanger the safety and compliance of patients in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Routine blood;Liver and kidney function;PET-CT;CRR;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone marrow puncture;DOR;PFS; | — |
Countries
China
Contacts
Public ContactZhiming Li
Cancer Prevention and Treatment Center, Sun Yat-Sen University
Outcome results
None listed